We are seeking an experienced QA Specialist for Design Assurance of our instruments.

Dako Denmark, an Agilent technologies company is looking for an experienced QA Specialist to work within cross functional reagent product development teams in an international environment.

We are looking for a candidate with excellent communication and collaboration skills that takes a pride in working with the project teams to deliver high quality products and documentation for our instrument solutions.
In this role you will represent Quality Assurance in design and development projects ensuring compliance to Dako's quality management system and external requirements in general, especially with regards to Design Control, Risk Management, Change Control, Product Verification & Validation and Process validation.
You will have a close collaboration with R&D, RA, Operation and Service to assure high quality throughout the development process. You will report to the Manager of QA Design Assurance.

As a QA Instrument Specialist you will also be responsible for driving initiatives and changes to the current processes as well as collaborating with international colleagues to achieve corporate goals.

This position has the responsibility for:

This position is responsible for managing compliance issues and act on QA/RA initiatives to ensure overall compliance in DAKO's QMS related processes.
This position has the responsibility for:

- QA handling, review and support of QMS documents and CAPA
- Participate during costumer audits or regulatory inspections
- Collaborating with relevant stakeholders at site Glostrup and Carpinteria concerning performance of daily QA tasks
- Handling for Quality agreements and Questionnaires
- QA handling and approval of changes
- Drive QA compliance and QA improvement activities, when relevant e.g. procedures
- Develop and maintain implementation plan and/or quality plan, when relevant
- Keeping updated with relevant regulations and scientific knowledge within the area as well as in Agilent's quality management system
- Improving knowledge and competences by internal on-the-job training
- Working in accordance with Agilent's quality management system, IVD, ISO13485/MDSAP, 21CFR Part 820 (FDA)